ON DEMAND

Software as a Medical Device: Building for Compliance and Innovation

Developing Software as a Medical Device (SaMD) requires balancing innovation with regulatory rigor. In this webinar, Shawnnah Monterrey, Founder and CEO of BeanStock Ventures, will share practical strategies to help you design compliant software from the start, accelerate FDA clearance, and manage post-market obligations with confidence.

You’ll learn how to:

• Align software development with FDA and IEC 62304 requirements while avoiding common DHF pitfalls.
• Select the best regulatory pathway (510(k), 3P510(k), or De Novo) to shorten timelines and reduce risk.
• Build a regulatory strategy that supports your product roadmap and investor milestones.

Whether you’re preparing for your first SaMD submission or looking to strengthen compliance for existing devices, this session will equip you with the tools to innovate while meeting regulatory demands.